FDA Approves Tirzepatide for Obstructive Sleep Apnea in Obesity

The US Food and Drug Administration (FDA) has approved tirzepatide (Zepbound) as the first and only prescription treatment for adults with moderate-to-severe obstructive sleep apnea (OSA) and obesity.1

Announced by Eli Lilly and Company on December 20, 2024, adults with OSA receiving tirzepatide achieved an average of up to 20% weight loss while experiencing ≥25 fewer breathing interruptions for each hour slept.

“Too often, OSA is brushed off as ‘just snoring’ – but it’s far more than that. It is important to understand OSA symptoms and know that treatments are available, including new options like [tirzepatide],” Julie Flygare, JD, president and chief executive officer of Project Sleep, said in a statement.1 “We hope this will spark more meaningful conversations between patients and health care providers and ultimately lead to better health outcomes.”

OSA is a breathing disorder during sleep, marked by the partial or complete collapse of the upper airway.2 This collapse can result in apnea, hypopnea, drops in oxygen levels, and/or brief awakenings from sleep. While snoring is a classic sign of OSA, other prominent symptoms include fatigue, excessive daytime sleepiness, and fragmented sleep, which can make the condition easy to miss.

Tirzepatide was initially FDA-approved in November 2023 for the treatment of adults with obesity or overweight who also experience weight-related medical problems, based on positive results from the SURMOUNT-1 and SURMOUNT-2 trials.3 It is the first and only dual-activating glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) agonist for obesity, tackling an underlying cause of excess weight.

Regulators have now awarded approval to tirzepatide for moderate-to-severe OSA and obesity based on positive data from the Phase 3 SURMOUNT-OSA clinical trial.1 The trial assessed tirzepatide 10 mg or 15 mg in 469 adults with OSA and obesity irrespective of positive airway pressure (PAP) therapy over 52 weeks.4

Among patients not on PAP therapy, tirzepatide was approximately 5 times more effective than placebo in reducing breathing disruptions, achieving 25 fewer hourly breathing disruptions compared with 5 for the placebo cohort. For those on PAP therapy, tirzepatide demonstrated 29 fewer hourly breathing disruptions compared with 6 for placebo.

At the 1-year mark, approximately 42% of adults treated with tirzepatide and 50% of those on tirzepatide plus PAP therapy experienced remission or mild, non-symptomatic OSA. The respective percentages for the placebo-treated cohorts were 16% and 14%, respectively.

Adults treated with tirzepatide also saw an average reduction of 18% body weight (~45 lbs), while those on tirzepatide plus PAP therapy lost an average of 20% body weight (~50 lbs), compared with 2% (~4 lbs) and 2% (~6 lbs) on placebo, respectively.

Safety data reported in SURMOUNT-OSA suggested the observed safety profile was similar to the profile reported in the SURMOUNT and SURPASS trials. The most common events related to tirzepatide were gastrointestinal-related and considered mild to moderate in severity.

In the release, Eli Lilly indicated tirzepatide should be used with a reduced-calorie diet and increased physical activity to assist adults with moderate-to-severe OSA and obesity in improving their sleep disorder.

“[Tirzepatide] is the first medication that significantly improves moderate-to-severe OSA and aids in long-term weight loss in adults with obesity,” Patrik Jonsson, executive vice president and president of Lilly Cardiometabolic Health and Lilly USA, said in a statement.1 “Nearly half of clinical trial patients saw such improvements that they no longer had symptoms associated with OSA, marking a critical step forward in reducing the burden of this disease and its interconnected health challenges.”

References

1. FDA approves Zepbound® (tirzepatide) as the first and only prescription medicine for moderate-to-severe obstructive sleep apnea in adults with obesity. Eli Lilly and Company. December 20, 2024. Accessed December 20, 2024. https://investor.lilly.com/news-releases/news-release-details/fda-approves-zepboundr-tirzepatide-first-and-only-prescription.
2. Slowik JM, Sankari A, Collen JF. Obstructive Sleep Apnea. [Updated 2024 Mar 21]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK459252/
3. Campbell P. FDA approves Tirzepatide (Zepbound) for Chronic Weight Management. HCP Live. November 8, 2023. Accessed December 20, 2024. https://www.hcplive.com/view/fda-approves-tirzepatide-zepbound-chronic-weight-management.
4. Campbell P. Tirzepatide shows benefit in obstructive sleep apnea, surmount-osa trial. HCP Live. April 17, 2024. Accessed December 20, 2024. https://www.hcplive.com/view/tirzepatide-shows-benefit-in-obstructive-sleep-apnea-surmount-osa-trial.